Use of fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Uncontrolled Asthma Subjects and Controlled Asthma Subjects

Part of paid clinical trials in Stockton, California.

Sponsor
Biometry Inc
Study ID
NCT07228026
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • fenoTRACK Device — DEVICE
    Home FeNO Monitoring: FeNO measurement will be performed. POC Longitudinal Response to Treatment: FeNO measurement will be performed in the office both the simulated home environment and POC environment.

Study Details

This study incorporates objectives directed at two subject cohorts: 1. Uncontrolled Adult and Pediatric Asthma Subjects: To demonstrate a statistically significant and clinically meaningful decline in Point Of Care (POC) FeNO as measured by the fenoTRACK device, after an approximately 2-week course of corticosteroid therapy in adults and children with non-steroid treated uncontrolled asthma. 2. Controlled Adult and Pediatric Asthma Subjects: * To evaluate within-session clinical precision during Visit 1 and Visit 2 for the fenoTRACK device for simulated at home FeNO, and at POC * To evaluate within-session clinical precision for home fenoTRACK use

Key Dates

Start date
Sep 17, 2025
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
160 participants (estimated)

Arms

  • Arm: Uncontrolled Asthma Subjects
    fenoTRACK for Uncontrolled Adult and Pediatric Asthma Subjects
  • Arm: Controlled Asthma Subjects
    fenoTRACK for Controlled Adult and Pediatric Asthma Subjects

Primary Outcome Measure

Uncontrolled Cohort - Magnitude of change in FeNO Values [ Time Frame: Visit 2 (Day 14) ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Bensch Clinical Research LLCStocktonCalifornia95207
Tara Clary
[email protected]
209-951-6741
AllerVie Clinical ResearchPanama CityFlorida32405
Lauren Green
[email protected]
AllerVie Clinical ResearchColumbusGeorgia31904
Matti Sherer
[email protected]
Paul A Shapero MDBangorMaine04401
Michelle Doucette
[email protected]
AllerVie Clinical ResearchEllicott CityMaryland21043
Chase Nichols
[email protected]
AllerVie Clinical ResearchGlenn DaleMaryland20769
Chase Nichols
[email protected]
Nebraska Medical Research Institute, Inc.BellevueNebraska68123-4303
Wendy Paulson
[email protected]
Allergy Partners Clinical ResearchAshevilleNorth Carolina28803
Karen Murdock
[email protected]
Toledo Institute of Clinical Research IncToledoOhio43617
Faheem Husain
[email protected]
Orion Clinical ResearchAustinTexas78759
Faye Nunnelee
[email protected]
Pharmaceutical Research & Consulting, Inc.DallasTexas75231
Katrina Goldie
[email protected]
Western Sky Medical ResearchEl PasoTexas79912
Allergy, Asthma & Sinus Center, S.C.GreenfieldWisconsin53228
Jennifer Kuhl
[email protected]

Find similar trials in Stockton, CA

By condition
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By research site
Bensch Clinical Research LLC· Stockton, CAAllerVie Clinical Research· Panama City, FLAllerVie Clinical Research· Columbus, GAPaul A Shapero MD· Bangor, MEAllerVie Clinical Research· Ellicott City, MDAllerVie Clinical Research· Glenn Dale, MD

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